HPLC, GC, IC method development, Validation and Transfer for API, complex OSD, complex generics products like long acting injectables, nasal sprays, peptide injections, peptide OSDs, oncology and Topical products etc using various analytical technique.
Expertly in peptide characterization. Well versed with USP/EP/BP/IP and various current regulatory guidelines ICH/ EMEA/ FDA Hands on experience on Nitrosamine and Genotoxic impurities method development, M.Pharm / M.Sc
To monitor the Demo, Scale up, exhibit, and launch batches. To take scale up batch, Exhibit batches and work on Trouble shooting. To perform investigation for Deviation/ OOS/ OOT observed at plant.
Exposure of analysis for Finished Products, Stability Samples and Raw Materials. Having Knowledge of Analytical Method Validation, Verification and Method Transfer. Having skill for data interpretation, troubleshooting. Pharma knowledge of Solid orals and Quality process.
M.Sc. / M.Pharm, Technically competent on analytical method development and Validation of complex products like liposomes, transdermal, long acting injectable, suspensions, Nano particles, Microspheres, topicals and peptides. Responsible for developing, establishing, and validating analytical testing methodologies, transfer; ensure all analytical testing activities are in compliance with applicable regulatory guidance.
Formulation development of Injectable including development, execution, filing and approval of Complex Injectables viz. Liposomes, Peptides, long acting emulsions, suspensions, in-situ gels, Lyophilised injectable etc.
HPLC, GC method development for OSD & API having exposure to regulated, Semi Regulated and India markets including Complex generic, F2F, Topical and Dermaceuticals, Peptides, Oncology.